Roundtables

Dr. Cho: I utilize artificial disc re- placements and minimally invasive tech- niques when appropriate. I am waiting for more evidence on stem cell tech- nology. Dr. Perez-Cruet: We are using MIS technologies that reduce cost while im- proving fusion rates, facilitating MIS procedures and reducing radi- ation exposure to surgeons. Many of these have been developed working with ompson MIS. Q: What are some of the roadblocks to innovation in spine surgery? Dr. Hartl: e lack of spine surgeons who are interested in conducting spi- nal research. We have a great lack of understanding about what is causing degen- erative spine and why it causes pain. e research that is necessary to under- stand these pathologies better, but not a lot of spine surgeons are interested in doing it. Also, there is a lack of infrastructure in which to conduct this research. Another problem is the tendency among spine surgeons to focus on instru- mentation and fusion surgery. ey are so focused on implants and that makes it difficult to open them up to other treatment options such as mini- mally invasive spine surger- ies or biologics that can help avoid fusions. Dr. Perez-Cruet: One of the biggest roadblocks is finding good partners to work with to develop these tech- nologies. Also, it takes money and re- sources. Currently, there is a concern amongst the companies about making large investments in healthcare when they are not sure if they are going to be re- imbursed for developing these technologies. Whether the current changes in healthcare will foster reimbursement for these technologies remains to be seen. Dr. Cho: I think it would be the cost. In order to run an investigational device exemption trial, companies need to spend millions of dollars. I don't know how this problem can be overcome. Medical research is expen- sive and we don't want to cut corners either. Dr. Schuler: e biggest roadblock is insurance companies, governmental payers and third-party payers denying physicians and patients the ability to undergo contemporary treatments and denying physicians the ability to per- form these modern surgical advances. We are seeing an enormous rise in denials for patients to certain types of care and an increase length of time for approvals for all procedures. To overcome this negative process, physi- cians need to continue producing data showing which techniques work most effectively. is needs to be financed "We need to be able to foster innovation from a regulatory and governmental standpoint. We need to think about how we can make bringing products to the marketplace easier and in ways that are not cost-prohibitive." -Dr. Mick Perez-Cruet, William Beaumont Hospital Innovation in Spine: Can Anything Stem the Flow? 3 investments in healthcare when they are not sure if they are going to be re- imbursed for developing these technologies. Whether the current changes in healthcare will foster reimbursement for these technologies remains to be seen. Dr. Cho: I think it would be the cost. In order to run an investigational device exemption trial, companies need to spend millions of dollars. I don't know how this problem can be overcome. Medical research is expensive and we don't want to cut corners either. Dr. Schuler: The biggest roadblock is insurance companies, governmental payers and third-party payers denying physicians and patients the ability to undergo contemporary treatments and denying physicians the ability to per- form these modern surgical advances. We are seeing an enormous rise in denials for patients to certain types of care and an increase length of time for approvals for all procedures. To overcome this negative process, physicians need to continue producing data showing which techniques work most effectively. This needs to be financed through patient-centered funding programs and nonprofits, not corporate funding. The insurers and the third-party payers are discrediting research funded by corporations and are claiming that there is a conflict of interest. Payers are choosing the studies that support their reimbursement policies and are deny- ing any studies that counter their financially motivated coverage decisions. This is unethical, and it is wrong. Q: How can surgeons overcome some of the regulatory burdens on innovation? Dr. Perez-Cruet: We need to be able to foster innovation from a regulatory and governmental standpoint. We need to think about how we can make bringing products to the marketplace easier and in ways that are not cost- prohibitive. There are ways in which it could be more streamlined. Also, there needs to be legislation that protects innovation. There should not be a huge liability burden for bringing new technologies to the marketplace. Q: Beyond strictly technology, how are surgeons evolving their approach to provide better care for patients? Dr. Carlson: We are always looking for patient-specific improvements in our procedures. With advancing technology, some of the more complex procedures can now be done as outpatient. Patients don't really want to stay in a hospital overnight. The patients understand the need for the operating room but the po- tential risks in staying in the hospital environment frightens most patients. From wrong medications and wrong dosing to risks of hospital-acquired infections, patients don't want to add to the potential complications of their procedures. Q: Will the current healthcare environment bring spine surgery innovation to a standstill? Dr. Carlson: Advances in spinal care will continue although it maybe slowed by changes in the healthcare system. As patients demand improvements in their care, it will be the healthcare system that may not be able to respond quickly enough to the demand. There will always be a demand for the inno- vative care that provides the best outcome, but the system is slow and bulky and will lag behind the desires of the patients. I believe over the next few years, healthcare delivery will change drastically. Unfortunately, I see the current system as a hindrance to advancement. This means that patients will seek care outside of the system anytime they have a chance. This will slow the ability of the best and brightest among us to make the improvements that will be demanded in the future. I see most surgeries trending toward outpatient environments and hospitals becoming less rel- evant to the healthcare systems as a whole. Dr. Perez-Cruet: I don't think it will bring innovation to a standstill. Compa- nies will have to foster innovations that provide cost-effective care. There will always be value in products that improve healthcare for patients. Q: What do you hope to see in terms of spine surgery innovation in the next five to 10 years? Dr. Perez-Cruet: I think we can do a better job understanding the patho- physiology of some of the disorders that we treat, so that we can enable more focused treatments, which can provide patients with really improved quality of life. A more focused approach addressing the underlying cause of the pa- tient's symptoms is what we need. Additionally, I feel that biologic restora- tion of the spinal column — that is, intervertebral disc via stem cells — may become a reality. Dr. Schuler: Regenerative techniques, which will obviate the need for many surgeries. The more we can heal through regenerative treatments, the more the patient can avoid or procrastinate the need for surgery. Dr. Cho: I would like to see long-term follow-up studies on cervical artificial discs. Hopefully, they will answer whether this technology can decrease the incidence of adjacent segment disease and also stay functional over time. If there is a way to decrease radiation exposure during minimally invasive surgery, I think that would be a huge step forward. I would like to see more data on biologics such as stem cell technology before they are applied in hu- mans. n Medtronic Spine, based in Memphis, Tenn., is the global leader in today's spine market and is committed to advancing the treatment of spinal conditions. Medtronic Spine collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of- the-art products and technologies for orthopedic and spinal conditions. The Medtronic Spine division is the second largest division at Medtronic, employing 5,600 people worldwide, with approximately 1,300 employees in Memphis, and annual revenue of $3.1 billion. Anesthetics are obviously from patient de- be used to decrease fewer side effects that require a hospital time to provide pain activity levels. spine surgery although it maybe slowed improvements in be able to respond demand for the inno- is slow and bulky over the next few advancement. This anytime they have a among us to make see most surgeries becoming less rel- standstill. Compa- cost-effective care. There will patients. surgery innovation understanding the patho- we can enable more improved quality underlying cause of the pa- biologic restora- stem cells — may the need for many treatments, the more on cervical artificial can decrease the functional over time. minimally invasive would like to see more are applied in hu-

• Cover